Head of Integrated Trial Process, PRS

Job Description Summary

The Head of Integrated Trial Process, PRS is responsible for ensuring efficiency, quality, and compliance in the end-to-end clinical trial process, while serving as Quality System Owner (QSO) for the Clinical Trial Quality System (CTQS). The role requires fostering strong collaboration with Line Functions to drive cross-functional integration and aligned ways of working. This position leads the design, monitoring, and continuous improvement of trial processes to enable business impact. By building and managing a high-performing team of Global Process Owners and Process Managers, the Head of Integrated Trial Process delivers results that strengthen process execution and accelerate trial delivery.

Job Description

Major accountabilities :

Build, lead and develop a high-performing team of Global Process Owners and Process Managers, fostering a culture of collaboration, accountability, and value delivery

Define and execute a compelling vision for integrated trial processes and the Clinical Trial Quality System (CTQS), ensuring efficiency, quality, and compliance across the end-to-end lifecycle. This includes driving clarity and simplicity, holistic process management, effective audit / inspection readiness, and the use of KPIs and metrics to monitor and sustain process health.

Foster strong collaboration with Global Line Functions, matrix teams' leaders and senior management to drive cross-functional process integration, alignment on strategy, and shared ownership of outcomes.

Prioritize and lead process transformation initiatives that maximize business impact, focusing on simplification, automation, and innovative approaches.

Capture and communicate business value of operational efficiencies through measurable outcomes and data-driven insights.

Promote and apply structured process improvement methodologies (e.g., kaizen, workshops, lean approaches) with active cross-functional participation.

Act as a change leader, enabling mindset and behaviour shifts that embed efficiency, quality, and continuous improvement across Research and Development.

Engage and influence a broad network of senior leaders and stakeholders to ensure alignment, collaboration, and sustained adoption of integrated trial processes.

Minimum Requirements :

Education (minimum / desirable) : Minimum : University degree in Life Science, quantitative science or business. Desirable Master of Business Administration or equivalent

Languages : Proficiency in English (read / write / speak)

Relevant Experience :

Deep knowledge of drug development and end-to-end clinical trial processes, with expertise in clinical systems, regulatory requirements, and business change management.

Proven ability to assess and respond to internal and external changes impacting trial processes, supporting systems, and training requirements.

Exposure to digital transformation and innovative technologies, including leveraging automation, data, and AI-enabled solutions to enhance process efficiency and decision-making. Demonstrated experience in defining and applying metrics to monitor process health, efficiency, and continuous improvement.

Successful track record in clinical development, with strong Clinical Operations experience highly desirable.

Strategic thinker with a focus on innovation, long-term planning, and process optimization to drive efficiency, compliance, and quality.

Experience simplifying and standardizing processes, including authoring and managing quality documentation.

Strong record of cross-functional leadership and collaboration across multiple functions within the clinical development value chain.

Established people leader with experience in building, mentoring, and developing high-performing teams, fostering collaboration, accountability, and career growth.

Ensure oversight and continuous improvement of the Clinical Trial Quality System, including the Annual Quality System Review, in alignment with Global QMS requirements. Represent PRS in key governance bodies and committees, bringing forward the perspective of integrated trial processes.

Skills Desired

Budget Management, Clinical Trials, Coaching, Compliance, Cross-Functional Teams, Leadership, People Management, Risk Management, Risk Monitoring, Strategy